The woman who received the first-ever near-total face transplant in the United States told her doctor she has regained her self-confidence, said Dr. Maria Siemionow, head of plastic surgery research at the Cleveland Clinic and leader of the transplant team.
The patient, who prefers to be anonymous, is finally able to breathe through her nose, smell, eat solid foods and drink out of a cup, Siemionow told participants of the annual meeting of the American Association for the Advancement of Science in Chicago over the weekend.
Innovation as research is a common (and necessary) way by which the science of surgery is advanced. Some innovations in surgical procedures occur on the fly, in individual operating rooms, often as a result of necessity or desperation. Ethics review boards only learn about those kinds of innovations when larger trials are proposed to test more rigorously the innovation that worked or looked promising the first time around. This case is different, however. Siemionow, a researcher with twenty years research experience on facial transplanatation, got approval from the IRB at Cleveland Clinic to conduct the transplant.
For even the most experienced research ethics board members, a protocol like this would be challenging to review. It would, for example, be unusually difficult to assess potential benefits against risks of harm in a case like this. A review would have presumably required significant expertise on the innovative methodology as well as substantial information on the criteria for a potential patient that would be eligible for this innovation. For background reference, one would have only information from three successfully completed facial transplants (without knowledge of long term risks and outcomes). To some extent, one would be approving not just a research study per se, but essentially providing permission for a surgeon to collaborate with a patient (who has no other realistic options for treatment) seeking his or her consent to undergo a potentially life-changing surgical innovation, the long term risks and benefits of which are unclear.
Innovation is important and necessary. It provides opportunities for individual patients who, as in this case, have no other viable options. As the science of surgery and transplant continues to advance in this way, ethics review boards who deal with clinical research arguably will need to be prepared to deal with more and more innovation as research.
(I blogged back in October about Double arm transplant, and focused in particular on whether such a transplant counted as innovation or as research.)